plus 4, Former NIH director: ObamaCare an attack on patient choice - Hotair.com |
- Former NIH director: ObamaCare an attack on patient choice - Hotair.com
- Breast-cancer survivor: Follow your own heart about mammography - Dallas Morning News
- The Healthcare Debate Is A Kabuki Theatre Of Incoherence - The Business Insider
- Komen for the Cure founder Nancy Brinker blasts proposed new ... - Dallas Morning News
- Amgen Recognized for Best Pipeline and Best New Drug at Scrip Awards - Stockhouse
| Former NIH director: ObamaCare an attack on patient choice - Hotair.com Posted: 23 Nov 2009 12:24 PM PST
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| Breast-cancer survivor: Follow your own heart about mammography - Dallas Morning News Posted: 23 Nov 2009 11:56 AM PST Since long before the U.S. Preventive Services Task Force changed its guidelines on breast cancer screening, women have been debating the pros and cons of mammography, often while donning a hospital gown and sitting in the waiting room of a mammography center. Generally the conversation goes something like this: "God, I hate this test." "Me too. I got a callback. But they said not to worry." "So you're not worried? "No, I'm freaking out." Survivors learn early on that cancer is a game of wait and see and that every test begets another. I was in a breast surgeon's waiting room recently, sitting next to two women in their 20s. I overheard one of them, a breast cancer survivor, giggling nonstop. She sheepishly admitted to her friend that she had smoked pot before her appointment. "I couldn't take another appointment straight," she said. The new guidelines – that women wait until age 50 to start having routine mammograms, and that no benefit has been shown for clinical breast examination or breast self-examination – conflict with other expert advice, leaving many women asking themselves: To test, or not to test? As a cancer survivor myself who, at 45, found a breast lump during a self-exam, I'm well aware that mammograms are unlikely to reveal all that lurks within the dense breast tissue of a young woman. Even when my lump was palpable, a mammogram didn't detect it. Only a sonogram confirmed it was there. My brother, a cancer researcher, told me that although I'd had four mammograms over four years, the lump had been growing undetected for around seven. And, as later testing revealed, so had several other lumps in each breast, some of which have since been removed, others of which have taken up permanent residence and are checked several times a year by my doctors. According to the task force report, breast cancer is the second-leading cause of cancer-related deaths among U.S. women, after lung cancer, killing 40,480 women in 2008. So the real question, it seems, is not whether women under 50 need to have regular testing, but when other, more accurate if not more individualized tests will be available to take mammography's place. When it came time for me to make a decision about post-surgical treatment, my breast surgeon told me about a new test called Oncotype, which compiles data about women with cancers like mine. I learned I qualified for their pilot program. The results showed that the chances of my cancer's returning were lower than someone developing breast cancer for the first time. Once I healed from surgery, I skipped the chemo and went straight to radiation therapy. I've never looked back. Until now. Had these new guidelines been in place before I had breast cancer, I might never have found my lump – and had I found it, might never have had a mammogram or a biopsy. And, had I decided to have testing and treatment, there might have been a whole series of insurance obstacles to overcome. The key to navigating today's world of breast testing – to have the test or not have the test – is to arm yourself with information, find a doctor willing to answer your questions, and most important, to employ your instincts, follow them, and make your voice known. Doing this not only brought me clarity and a sense of control, it also helped distance me from my own initial emotional response. In the end, it's about being OK with whatever decision you make, regardless of how many times the medical community changes its collective mind. Melissa T. Shultz is a freelance writer living in the Dallas area.
Some suggested links for answers about breast cancer: U.S. Dept. of Health and Human Services Guidelines: www.ahrq.gov/clinic/uspstf/ uspsbrca.htm General breast cancer information: •National Cancer Institute: www.cancer.gov •American Cancer Society: www.cancer.org •National Women's Health Network: www.nwhn.org •The University of Texas M.D. Anderson Cancer Center: www.mdanderson.org This content has passed through fivefilters.org. |
| The Healthcare Debate Is A Kabuki Theatre Of Incoherence - The Business Insider Posted: 23 Nov 2009 12:17 PM PST This post originally appeared at The Atlantic I spent eight hours this weekend watching the Senate debate on whether to proceed with debating on whether to pass a health care bill. This was largely a sort of kabuki ritual, since Senate Majority Leader Harry Reid already knew that he had the sixty votes needed to stop a Republican filibuster. But it tells you what the talking points are on each side, which is going to matter as the debate actually plays out. The Republican position is fairly incoherent. The major talking points are these:
Somewhat to my surprise, John McCain was on fire, in full on "flaming sword of righteousness" mode. He was practically shaking with anger as he called out the government for negotiating with the pharma companies, and yelled at the pharmas for raising their prices this year. Pharma seems to have followed a standard "Memorial Day Sale" strategy--they've raised prices by about 10% this year, in preparation for the deep discounts they'll have to offer in the future. John McCain thought that this was terrible, and said so, to awkward silence from his colleagues. They brightened up considerably when he said "Shame on the AARP" for endorsing this plan that does its members no good, accused them of getting paid off, and told people to tear up their AARP cards. He and Bob Corker were pretty much the high points. The rest was mostly boilerplate. Luckily for the Republicans, they weren't exactly playing against the varsity. The Democrats had their own set of uncompelling talking points:
The best talking points on both sides were, sadly, anecdotes. Democrats had the predictable parade of people who were denied coverage for various treatments. Republicans had doctors who cannot afford to take Medicaid, hospitals which can't survive on Medicare and Medicaid reimbursement levels, and Senator John Barasso, whose wife was diagnosed with breast cancer by a mammogram in her early forties. From TheAtlantic – shaping the national debate on the most critical issues of our times, from politics, business, and the economy, to technology, arts, and culture. This content has passed through fivefilters.org. |
| Komen for the Cure founder Nancy Brinker blasts proposed new ... - Dallas Morning News Posted: 23 Nov 2009 11:56 AM PST WASHINGTON – Nancy Brinker, founder of Susan G. Komen for the Cure, said today that a recent federal task force recommendation that most women should cut back on annual mammograms sends the wrong signals, and that opponents are "justifiably outraged." "We've urged people to get screened," she said. "Now they have heard they shouldn't bother. That's dangerous." Last week, the U.S. Preventive Services Task Force announced that women in their 40s should stop having annual mammograms and said women older than 50 should get the exam every other year, unless a family history or other factors put them in an elevated risk category. The 16-member panel also discouraged the teaching of self-breast exams. Brinker, a former Dallas resident, told a news conference at the National Press Club that women should stick with current methods of breast cancer screening and that Komen for the Cure would not change its guidelines. "As a breast cancer survivor, I know that mammography saves lives," she said. "Even this report says so." The task force acknowledged that screening is an effective way to catch breast cancer, but said too many screenings – at too early an age – results in an abundance of false positives, unnecessary procedures and increased anxiety. Brinker takes issue with that. Most women are mature enough to handle the added worries, and any pitfalls are heavily outweighed by the success of finding and treating cancer early, she said. "The women I have heard from, thousands and thousands, are justifiably outraged," she said. "They believe the mammogram they had saved their lives. They believe they have done the right things." Brinker, who served as ambassador to Hungary and chief of protocol under President George W. Bush, founded the Komen foundation in 1982 in honor of her sister, who died of breast cancer at age 36. GOP Sen. Kay Bailey Hutchison of Texas is among the task force critics who warn the guidelines are a harbinger of "rationing" under health care legislation Congress is debating. Brinker doesn't agree with those warnings, but promised to keep a close eye on insurers. "Any insurance company who is thinking that this report can be used as a way to reduce coverage for mammography, now or at some point, know this: We will be watching very carefully," she said. But while Brinker views the task force report as flawed, she said it could provide an impetus for improved breast cancer screening technology, some of which is nearly 50 years old. Technology will be key to the next breakthrough, she said, and she implored Congress to increase funding for breast cancer research. "We know mammography works, but we also know it is imperfect," she said. This content has passed through fivefilters.org.  This posting includes an audio/video/photo media file: Download Now |
| Amgen Recognized for Best Pipeline and Best New Drug at Scrip Awards - Stockhouse Posted: 23 Nov 2009 12:17 PM PST THOUSAND OAKS, Calif., Nov 23, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Amgen (Nasdaq: AMGN) was honored with two 2009 Scrip Awards, winning for Best Overall Pipeline and for Best New Drug for Nplate(R) (romiplostim), at a Nov. 18 ceremony in London. The Best Overall Pipeline award was presented to Amgen by Scrip in recognition of the size, quality, novelty and market potential of the company's pipeline, as well as its mix of candidates across development stages. According to the judges, Amgen's pipeline is notable for its focus on unmet clinical need. "We are very pleased to be honored by our industry peers with these two awards," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Over the past decade, we have worked very hard to develop a robust pipeline that focuses on novel therapeutics to treat serious illnesses." With more than 50 molecules in development, the majority of which target pathways that have not previously been addressed in humans, Amgen's pipeline includes potential new treatments for various cancers, asthma, diabetes, cardiovascular disease and many other life-threatening conditions. One of the most promising candidates in Amgen's pipeline, denosumab, is an in-house discovery that reflects a novel approach to treating bone loss and destruction. Amgen has filed for regulatory approval of denosumab in postmenopausal osteoporosis (PMO) and bone loss due to hormone ablation in breast and prostate cancer patients in the United States (U.S.), Europe, Switzerland, Canada and Australia. More information on Amgen's pipeline can be found at www.amgen.com. Nplate won the Best New Drug honor because of its novel mode of action and its focus on an unmet medical need. Nplate is indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP), under specific conditions that are further described below. Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. Nplate is the first platelet producer approved in both the U.S. and European Union (EU), and works by raising and sustaining platelet counts, representing a unique approach for the long-term treatment of this chronic disease. The annual Scrip Awards are independently judged by a panel of senior industry experts and are given to biotechnology and pharmaceutical companies for their contribution to the improvement of health care. Amgen was one of the biggest winners among the dozen companies honored at the 2009 awards event for "outstanding achievements in the field of drug development," according to Scrip's press release. For more information, visit the Scrip website. About Nplate Nplate was the first platelet producer approved in the EU, Canada, Australia, Russia and the U.S. for chronic ITP. Nplate also has received orphan designation for chronic ITP in the U.S. (2003), the EU (2005), Switzerland (2005) and Japan (2006). Nplate is the first treatment specifically developed for chronic ITP. It is also being investigated for potential use in pediatric ITP, myelodysplastic syndromes (MDS) and chemotherapy-induced thrombocytopenia (CIT). In the U.S., Nplate is indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts. In Europe, Nplate is indicated for the treatment of splenectomised adult chronic ITP patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Nplate may be considered as a second-line treatment for adult non-splenectomised ITP patients for whom surgery is contra-indicated. Important U.S. Nplate Safety Information Serious adverse reactions associated with Nplate in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate discontinuation. Additional risks include bone marrow fibrosis, thrombotic/thromboembolic complications, lack or loss of response to Nplate, and hematological malignancies and progression of malignancy in patients with a pre-existing hematological malignancy or MDS. Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP. CBCs, including platelet counts and peripheral blood smears, should be monitored prior to initiation, throughout, and following discontinuation of Nplate therapy. Nplate is available only through a restricted distribution program called Nplate(R) NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program. In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction. Important EU Nplate Safety Information The most common side effects are headache, fatigue, arthralgia, myalgia, injection site bruising, injection site pain, peripheral oedema, dizziness, muscle spasms, nausea, contusion, diarrhea, bone marrow disorder, influenza like illness, insomnia and pruritus. Reoccurrence of thrombocytopenia and bleeding after cessation of treatment and increased bone marrow reticulin have been associated with romiplostim treatment in the clinical trials. Thrombotic/thromboembolic complications, progression of existing hematopoietic malignancies or MDS, and effects on red and white blood cells are all potential risks associated with romiplostim treatment. As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein. About Denosumab In February 2009, the U.S. Food and Drug Administration (FDA) accepted the Biologic License Applications (BLA), submitted by Amgen for Prolia(TM) (denosumab) for the treatment and prevention of osteoporosis in postmenopausal women and treatment and prevention of bone loss in women and men receiving hormone therapy for either breast cancer or prostate cancer. On October 2009, the FDA issued Complete Response Letters for the BLA application for denosumab requesting additional information needed to complete the review of the applications for approval, including updated safety data. The FDA also requested a new clinical program to support approval of denosumab for the prevention of PMO and additional adequate and well-controlled clinical trials demonstrating the denosumab has no detrimental effects on either time-to disease progression or overall survival for cancer treatment-induced bone loss (in breast cancer and prostate cancer patients). Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. It is being studied in a range of other bone loss conditions including rheumatoid arthritis, and cancer treatment-induced bone loss (in breast cancer and prostate cancer patients), as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer. About Amgen Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com. Forward-Looking Statements This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended December 31, 2008, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company's results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign), difficulties or delays in manufacturing our products. In addition, sales of our products are affected by reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. CONTACT: Amgen, Thousand Oaks Mary Klem: (805) 447-6979 (media) John Shutter: (805) 447-1060 (investors) (Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO) SOURCE Amgen http://www.amgen.com Copyright (C) 2009 PR Newswire. All rights reservedThis content has passed through fivefilters.org. |
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